Kornimate/medical-research-clean huggingface dataset:
effect of music on patients in intensive care units

Conditions: Intensive Care Unit

Summary: the purpose of this study is to investigate the effects of patient-preferred music, relaxation music, and standard care environment on patients in intensive care units.

this study is a prospective randomized clinical trial. the purpose of this 4-stage study is to explore the effects of patient-preferred music, relaxation music, and standard care environment on patients in intensive care units. stage 1: recommendation of relaxation music by music therapists who serves as expert panel stage 2: analysis of recommended relaxation music by music therapists stage 3: content validation of relaxation music by healthy adults stage 4: comparison of patients' physiological, psychological, and biological responses to patient-preferred music, relaxation music, and standard care environment

Eligibility criteria:
inclusion criteria: communicative (non-intubated, non-sedated) * at least three days of admission (excluding day of admission) * 18 years or older * mean arterial blood pressure equal or greater than 65 throughout study * mean spo2 equal or greater than 90 throughout study * glasgow coma scale equal or greater than 14 * bilirubin level less than 5 * ammonia level less than 1 * hematocrit level greater than 15 * bun equal or less than 100 non-communicative (intubated, sedated) * at least three days of admission (excluding day of admission) * 18 years or older * mean arterial blood pressure equal or greater than 65 throughout study * mean spo2 equal or greater than 90 throughout study * glasgow coma scale equal or greater than 10 * bilirubin level less than 5 * ammonia level less than 1 * hematocrit level greater than 15 * bun equal or less than 100 exclusion criteria: communicative (non-intubated, non-sedated) * patients admitted for or less than 3 days * patients with hearing impairments * patients with neurological impairments that might impair their ability to process information * patients on glucocorticoid medications * patients with mental health diagnoses and currently experiencing active psychosis such as hallucinations and/or delusions * patient's condition altered dramatically over the 3 days of research non-communicative (intubated, sedated) * patients admitted for or less than 3 days * patients with hearing impairments * patients with neurological impairments that might impair their ability to process information * patients on glucocorticoid medications * patients with mental health diagnoses and currently experiencing active psychosis such as hallucinations and/or delusions * patient's condition altered dramatically over the 3 days of research

Keywords: icu environment auditory stimulation properties of relaxation music music music therapy pain anxiety cortisol iga biomarkers relaxation music
comparison of the effects of two glaucoma drugs over 24 hours (0507a-137)(completed)

Conditions: Glaucoma; Ocular Hypertension

Summary: this study is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day.


Eligibility criteria:
inclusion criteria: * patients with glaucoma or ocular hypertension exclusion criteria: * other eye conditions * poor vision * recent eye surgery * use of contact lenses * nursing or pregnant women * use of some other selected medications * drug or alcohol abuse * asthma * slow heart beat * allergy or previous reaction to study drugs

Keywords: ocular hypertension (excessive pressure in the eye)
biomarkers identification of anti-tumor necrosis factor (tnf) α agent's efficacy in ankylosing spondylitis patients

Conditions: Ankylosing Spondylitis

Summary: to identify new candidate genes and proteins that are differentially expressed in responders' vs non-responders to anti-tnf alpha therapy at the several time points the investigators will use the transcriptomic and proteomic analyses. demonstrate a link between gene expression and protein markers regarding prediction to anti-tnf alpha therapy efficacy.


Eligibility criteria:
inclusion criteria: * as according to portuguese society of rheumatology (spr) guidelines (1984 modified new york criteria, but allowing the use of mri as imagiological criteria) * patient enrolment followed national guidelines for tnf antagonist use for the treatment of as * adults between 18 to 75 years * ability to provide informed consent * corticosteroid therapy allowed (equivalent to ≤ 10 mg prednisone) and / or nsaid(nonsteroidal antiinflammatory drug), stable dose in 4 weeks before study initiation * adequate contraception (barrier or hormonal) in men and women of childbearing age (patients and their partners * adequate renal and hepatic function (2 times uln) exclusion criteria: * current pregnancy or breastfeeding * previous treatment with biologic dmard's (disease-modifying antirheumatic drug) * intraarticular injections or infiltrations of extraaxial joints and tendons within 28 days before or at screening, or intraarticular injections of sacroiliac joints ≤ 28 days before screening * history of rheumatic disorder other than as * other forms of spondylarthritis than as * any uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, unstable ischemic heart disease) * history or signs of demyelinating disease * malignancy (except for completely treated squamous or basal cell carcinoma) * moderate to severe heart failure (nyha class iii/iv) positive serology for hepatitis b, hepatitis c, or human immunodeficiency virus * active or latent tuberculosis (tb) or histoplasmosis or other severe infections such as sepsis, and opportunistic infections * infections requiring hospitalization or intravenous treatment with antibiotics within 30 days or oral treatment with antibiotics within 14 days before enrollment * ankylosis of the spine (syndesmophytes presence at all levels from d12 to s1 in x-ray (xr) lateral view) * hypersensitivity to the active substance or to any of the excipients

Keywords: ankylosing spondylitis adalimumab tnf-alpha agents spondyloarthritis biologic therapies as biomarkers efficacy prediction
np202 for treatment of post -stemi left ventricular systolic dysfunction

Conditions: ST Elevation Myocardial Infarction

Summary: np202 is an experimental drug being developed by armaron bio pty ltd for potential use as a treatment for people after they have had a heart attack (mi).

after someone has a mi, their heart 'remodels', which means that it changes in size and shape. this damage can lead to it being weaker and less efficient, and ultimately to major heart problems. there are some drugs currently available which help prevent remodelling and are used for treatment post-mi. however, there is still a high rate of remodelling and major heart problems in people post-mi. np202 works in a different way to the drugs that are currently approved, and has been shown in animal studies to prevent post-mi remodelling. this study will assess np202 versus placebo on remodelling over a 3 month treatment period, with 1 month follow up

Eligibility criteria:
inclusion criteria: * have had a confirmed st elevation myocardial infarction (stemi) in the previous 5 days, which met all of the following criteria; * ≥ 0.2mv st elevation in 2 or more v1 - v6 leads with presentation in a maximum of 12 hours of onset of symptoms * troponin levels \>10 x upper limit of normal (uln) at the site's local laboratory. * successful revascularisation by percutaneous coronary intervention (pci) * have left ventricular dysfunction post stemi as evidenced by left ventricular ejection fraction (lvef) ≤40% confirmed by echocardiogram at screening. * are receiving guideline-directed medical therapy for acute mi and post-mi left ventricular (lv) dysfunction according to national cardiology society/heart association stemi guidelines. exclusion criteria: * known cardiomyopathy or heart failure prior to mi. * cardiogenic shock and/or systolic blood pressure \<85mmhg at screening. * clinical history of ejection fraction ≤40% prior to this mi, or multiple prior mis. * daily use of non-steroidal anti-inflammatory drugs (nsaids) and/or cyclooxygenase-2 (cox-2) inhibitors in the past month. * presence of device/hardware incompatible with mri * estimated glomerular filtration rate (egfr) \<30ml/min * liver function tests 3 x uln due to non-cardiac disease * have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
kinesiophobia in patients undergoing total knee replacement surgery

Conditions: Kinesiophobia

Summary: providing information to the patient before surgery has important effects on the patient's self-care skills regarding the treatment and care process, reducing stress and reducing fears in the postoperative period. the primary aim of this study was to examine the effect of preoperative education on kinesiophobia in patients undergoing total knee replacement surgery. in addition, preoperative anxiety levels, time of first postoperative mobilization, number of steps in the first 24 hours after mobilization and pain levels of the patients will be evaluated as secondary outcomes.

kinesiophobia is known as the minimization of activities or avoidance of movement due to the fear that the pain caused by movement will negatively affect the person's life and the problem will occur again. it was first defined by miller, kopri and todd in 1990 at the american pain society meeting as excessive and unreasonable anxiety against physical movement and pain in the person, which occurs due to the person feeling vulnerable as a result of a painful injury or re-injury. kinesiophobia is one of the factors that contribute to the chronicization of pain in individuals after surgery; it can lead to negative patient behaviors on the disease in the surgical process. in addition, kinesiophobia can lead to movement limitation and movement limitation can lead to pain. since this vicious cycle may result in more pain and disability, the importance of the issue is increasing. it has also been shown that patients with high levels of kinesiophobia experience more pain and have a lower quality of life. this research project aims to provide an original approach in a field where studies on preventing or minimizing the effects of kinesiophobia on the surgical process and postoperative recovery process are limited. it is expected that nurses' interventions for kinesiophobia during the operation process will have positive effects on treatment and care. in this study, visual material-supported patient education will be provided to reduce the level of kinesiophobia associated with total knee replacement surgery.

Eligibility criteria:
inclusion criteria: * 65 years of age or older * planned surgery * speaking and understanding turkish * being admitted to the hospital at least one day before the surgery exclusion criteria: * visual, hearing and speech disabilities, * being mentally disabled, * having a psychiatric disorder or being in the process of treatment * having had knee replacement surgery before

Keywords: kinesiophobia knee replacement nursing education preoperative care
real-time nirs neurofeedback regulating brain cognitive function in obese individuals

Conditions: Obesity; Neurofeedback

Summary: to determine the efficacy of real-time fnirs neurofeedback for regulating the brain cognitive function in obese individuals.

in the current study, 60 obese subjects will be recruited, and they were randomly classified into the group who will receive real neurofeedback and the group who will receive sham neurofeedback. participants will receive the real-time neurofeedback for 12 times, 3 to 4 times a week, each time the real-time neurofeedback consists of 12 sessions of liftstone as the index reflecting the brain activity. sham group will receive the identical neurofeedback. all of the subjects will undergo magnetic resonance imaging scan, during which t1, diffusion tensor imaging, resting-state, and task fmri data will be collected. for task fmri scan, the participants will be asked to finish four cognitive task, including 2-back working memory, go/no-go task, willingness to pay for food, and delay discounting tasks. clinical measurements including bmi, eating behavior, psychiatric status will be assessed. those aforementioned examinations will be performed at before the neurofeedback, 6th times and the end of the treatment.

Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) ≥ 25 2. 18 to 65 years old 3. no severe mental disorders(depression; schizophrenia; bipolar disorder; etc.). exclusion criteria: 1. severe dysfunction of heart, liver, kidney and hematopoietic system 2. substance addiction 3. patients who cannot be treated with fmri or fnris neurofeedback 4. those who take other weight loss drugs.

Keywords: nirs fnirs neurofeedback obesity
interventions for lifestyle changes to promote weight reduction, a randomized controlled trial in primary health care

Conditions: Overweight/Obesity

Summary: the purpose of this study is to examine the effects of a weight reduction program in adults, seen in a primary care setting, with overweight/obesity perceived as a health problem or with diseases related to overweight/obesity and ambitions to achieve weight reduction as part of treatment.

patients seeking advice for overweight/obesity or illness related to overweight/obesity at eight primary health care centers in sweden were randomized either to intervention or control care groups with both dietary advice and individualized advice on increased regular physical activity. main outcome measures were reduction in body weight of 5 percent or more from study start.

Eligibility criteria:
inclusion criteria: * adult patients between 18 and 70 years of age who consulted or were in care for overweight/obesity with or without type 2 diabetes * hypertension, cvd * coronary heart disease (chd) * dyslipidemia * gallstone or musculoskeletal disorders exclusion criteria: * patients were not eligible if they were already taking part in another weight control program * understood the swedish language poorly * were mentally ill or had an alcohol or drug addiction. * nor were they eligible if they had a physical disability preventing intensified physical activity or were pregnant at study start.
vitamin d improves clinical manifestations in asthmatic children

Conditions: Asthma in Children

Summary: objectives: evaluation of the effect of vitamin d supplemental therapy (vdst) on clinical manifestation of bronchial asthma (ba) as judged by the international study of asthma and allergies in childhood (isaac) questionnaire and estimated serum levels of immunoglobulin e (ige). patients \& methods: scores of isaac questionnaire and blood samples were obtained for estimation of serum ige and 25-hydroxy vd (25-hvd) at booking time (t1) of 102 ba patients. vdst was provided as 2000 iu daily for 3 and 6 months for patients had moderate and mild hvd, respectively. at the end of 12-m after start of vdst (t2), isaac questionnaire and serum levels of 25-hvd and ige were re-evaluated and the percentage of change was calculated.


Eligibility criteria:
inclusion criteria: * patients in the age group of 6-14 years, free of exclusion criteria and complaining of chest wheezes were included in the study. exclusion criteria: * presence of acute asthmatic attack, current or recurrent chest infection, allergic dermatological disorders, chronic rhino-sinusitis, deviated nasal septum, other nasal or palatal congenital anomalies, history of chronic exposure to allergens, or living in areas characterized by air pollution, being passive smokers since birth, presence of autoimmune disorders, serum 25-hvd \>50 nmol/l and presence of clinically evident hvd.
pilot functional imaging study to evaluate mechanisms underlying chronic pain in breast cancer patients

Conditions: Pain; Breast Cancer

Summary: the purpose of this study is to better understand why some women with breast cancer develop chronic pain.

women with breast cancer who either have chronic pain or who do not have chronic pain will be asked to enroll. those who participate will have pictures taken of their brain using mri when they are lying still and also when pressure is being applied to their thumbnails. these pictures will be compared to patients without breast cancer who do not have pain and to those who have other types of pain, such as fibromyalgia. by taking and analyzing these pictures the investigators hope to understand more about why breast cancer survivors develop pain after their diagnosis and treatment. in the future the investigators hope to better treat the pain or possibly even prevent the pain from occurring in the first place.

Eligibility criteria:
inclusion criteria: * breast cancer survivor with and without chronic pain * able to undergo mri
a phase ii clinical trial of docetaxel, oxaliplatin combination chemotherapy in patients with stage iiib/iv non-adenocarcinoma, non-small cell lung cancer (nsclc) as second-line treatment

Conditions: Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous; Carcinoma, Large Cell

Summary: 1. goals the primary goal of this phase ii trial is to: evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with stage iiib/iv non-adenocarcinoma, non-small cell lung cancer (nsclc) as second-line treatment secondary goals are to: evaluate the treatment-related toxicities of this combination, investigate progression-free survival (pfs) and overall survival (os) in this population 2. design the proposed clinical trial is an open label, non-comparative, multicenter phase ii trial according to the two stage testing design by simon two-stage testing procedure


Eligibility criteria:
inclusion criteria: 1. patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically 2. patients must be ≥ 18 years old of age 3. ecog performance status ≤ 1 4. estimated life expectancy of more than 3 months 5. treatment with only one prior chemotherapy 6. at least one lesion that can be measured by imaging (ct/mri) according to the response evaluation criteria in solid tumors (recist v1.1) 7. adequate bone marrow function (absolute neutrophil count \[anc\] ≥ 1,500/µl, hemoglobin ≥ 9.0 g/dl \[correction by transfusion is acceptable\], and platelets ≥ 100,000/µl) 8. adequate kidney function (serum creatinine \< 1.5 x upper limit of normal \[uln\]) 9. adequate liver function (serum total bilirubin \< 1.5xuln; serum transaminases levels \< 2.5xunl) 10. provision of fully informed consent prior to any study specific procedures exclusion criteria: 1. pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception 2. patients who received prior chemotherapy including paclitaxel or docetaxel 3. patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years) 4. patients with defect of central nervous system (cns) or any psychiatric disorders and cns metastases 5. other serious illness or medical conditions a. clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment \[nyha class iii or iv\], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 av block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry b. liver cirrhosis (≥ child-pugh class b) c. history of significant neurologic or psychiatric disorders including dementia or seizures d. active uncontrolled infection e. other serious underlying medical conditions which could impair the ability of the patient to participate in the study 6. concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
comparison of the efficacy and safety of two different dose adjustment regimens for insulin degludec/insulin aspart in subjects with type 2 diabetes mellitus previously treated with insulin glargine

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa, asia, europe and the united states of america (usa). the aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (ideg/iasp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.


Eligibility criteria:
inclusion criteria: * type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to visit 2 (randomisation) * currently treated with iglar (insulin glargine) and up to 3 oral antidiabetic drugs (oads) (metformin, dpp-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). all antidiabetic treatments should have been ongoing for at least 12 weeks prior to visit 2 (randomisation) and doses should have been stable in this period of time * glycosylated haemoglobin (hba1c) 7.0-10.0% (both inclusive) by central laboratory analysis * body mass index (bmi) below or equal to 40 kg/m\^2 exclusion criteria: * treatment with glucagon-like peptide 1 (glp-1) receptor agonists or thiazolidinediones (tzds) both within the last 12 weeks prior to visit 2 (randomisation) * stroke; heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to visit 2 (randomisation) * uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg * recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator * life-threatening disease (e.g. cancer)
human phototoxicity test

Conditions: Sunscreening Agents

Summary: to determine the phototoxic potential of a topically applied article in human subjects.


Eligibility criteria:
inclusion criteria: * be male or female between the ages of 18 and 60 inclusive; * be lightly pigmented (fitzpatrick skin type i, ii, iii); * have read and signed the written informed consent form and have completed a hipaa authorization form in conformance with 45cfr parts 160 and 164; * be in general good health as determined by the subject's medical history and in the discretion of the investigator. exclusion criteria: * have a visible sunburn; * have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses; * must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product. * have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products.
enhancing quality of life in cancer patients through tailored nutrition support: a comprehensive approach

Conditions: Cancer

Summary: the study aims to investigate the impact of a dedicated nutritional assistance tool on patients with cancer and to measure its effects on several proposed indicators.


Eligibility criteria:
inclusion criteria: * patients affected by cancer, who decided to participate to the study, signed the informed consent and whose life expectancy is higher than 1 (one) year. exclusion criteria: * patients with an eating disorder of psychiatric or psychological origin, diagnosed before cancer treatment. * any other exclusion criteria as determined by the oncologist based on the patient's ability to successfully complete the program.